Table 3.
Injection technique | Treatment arm | Difference from baseline |
|||||
---|---|---|---|---|---|---|---|
Week 1 (mean ± SD) | Week 3 (mean ± SD) | Week 6 (mean ± SD) | Week 12 (mean ± SD) | Week 18 (mean ± SD) | Week 26 (mean ± SD) | ||
Anterolateral (AL) | Cingal | −36.2 ± 21.5 | −43.7 ± 18.7 | −44.3 ± 19.1 | −41.4 ± 21.2 | −43.8 ± 18.7 | −46.0 ± 15.8 |
Monovisc | −34.2 ± 18.1 | −40.7 ± 18.5 | −45.3 ± 15.9 | −45.2 ± 18.7 | −44.7 ± 23.4 | −44.5 ± 23.8 | |
Saline | −24.1 ± 14.0 | −29.8 ± 13.2 | −34.6 ± 12.8 | −30.3 ± 18.6 | −28.4 ± 25.9 | −32.1 ± 25.7 | |
ANOVA (P value) | .1285 | .0535 | .1224 | .0601 | .0526 | .1088 | |
Anteromedial (AM) | Cingal | −38.2 ± 22.2 | −43.1 ± 22.0 | −43.0 ± 23.2 | −43.9 ± 23.1 | −42.4 ± 23.2 | −46.4 ± 19.8 |
Monovisc | −27.7 ± 24.0 | −34.2 ± 24.5 | −39.0 ± 23.2 | −40.7 ± 24.5 | −39.9 ± 25.1 | −41.9 ± 24.0 | |
Saline | −27.1 ± 22.5 | −30.4 ± 22.1 | −38.2 ± 21.9 | −32.8 ± 25.8 | −37.0 ± 26.0 | −36.6 ± 21.5 | |
ANOVA (P value) | .0312* | .0383+ | .5752 | .1616 | .6438 | .1642 | |
Lateral midpatellar (LM) | Cingal | −30.4 ± 18.7 | −35.4 ± 18.3 | −36.2 ± 18.7 | −38.2 ± 17.4 | −36.7 ± 18.2 | −36.7 ± 18.1 |
Monovisc | −28.8 ± 20.2 | −31.8 ± 20.0 | −35.3 ± 18.3 | −33.1 ± 19.9 | −33.1 ± 21.6 | −34.1 ± 20.0 | |
Saline | −27.5 ± 16.0 | −33.1 ± 18.4 | −33.5 ± 21.8 | −29.3 ± 24.8 | −28.1 ± 21.6 | −30.1 ± 24.1 | |
ANOVA (P value) | .7671 | .5997 | .8258 | .1190 | .1716 | .3566 |
Abbreviations: ANOVA, analysis of variance; WOMAC, Western Ontario and McMaster Universities Arthritis Index.
Statistically significant result (P < .05). Cingal demonstrated a significantly greater reduction in pain at this visit compared with both Monovisc and saline (P = .0168 and .0458, respectively), with no significant difference between Monovisc and saline (P = .9154).
Statistically significant result (P < .05). Cingal demonstrated a significantly greater reduction in pain at this visit compared with both Monovisc and saline (P = .0449 and .0231, respectively), with no significant difference between Monovisc and saline (P = .4782).
Post hoc power analysis results at 12 weeks: 55% (AL), 38% (AM), and 43% (LM).